Trial Profile
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 20 Dec 2019
Price :
$35
*
At a glance
- Drugs Influenza virus vaccine (Primary)
- Indications Influenza virus infections
- Focus Pharmacodynamics; Registrational
- Sponsors Sanofi Pasteur
- 04 Nov 2019 According to an Sanofi media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. This FDA approval was based on data from this Phase 3 immunogenicity and safety study
- 17 Aug 2019 Results assessing safety and immunogenicity of a quadrivalent formulation of the high-dose split-virion inactivated influenza vaccine in adults published in the Vaccine
- 23 Apr 2018 Status changed from active, no longer recruiting to completed.